Author: David Balderson & Supriya Desai, Sciformix Corporation
Premarketing clinical safety and PV activities, and the technology infrastructure that supports it, are typically outsourced to multiple contract research organisations (CROs) as part of their clinical trial programmes. Employing multiple CROs based on how clinical programmes are managed often leads to safety data being reported to each clinical trial rather than at the product level, and data are often collected in different systems resulting in a lack of integration with little or no control over data standardization. This puts organizations at risk at the time of filing a marketing authorization application when it is important to review and analyse consolidated data, define the initial product label, and proactively identify and manage safety concerns.
Further, for many small to medium biopharmaceutical companies, having an internal resource-heavy, end-to-end safety and risk management system for marketed products is not practical as it diverts extensive time, effort and financial spend away from a company’s core activities of product development and marketing. Often, such organisations do not have a distinct established safety group and either the clinical development or regulatory groups are responsible for safety activities, leading to lack of focus on critical PV activities.